Entecavir treatment for chronic hepatitis B: Adaptation is not needed for the majority of naive patients with a partial virological response

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1002/hep.24406/abstract

Entecavir treatment for chronic hepatitis B: Adaptation is not needed for the

majority of naïve patients with a partial virological response†‡

Roeland Zoutendijk1, Jurriën G. P. Reijnders1, Brown2, Fabien Zoulim3,

Mutimer4, Katja Deterding5, Jörg sen6, Wolf Hofmann7,

Buti8, Santantonio9, Florian van Bömmel10, Pierre Pradat3, Ye Oo4, Marc

Luetgehetmann11, Berg10, Bettina E. Hansen1, Heiner Wedemeyer5, Harry L.

A. Janssen1,*,§, for the VIRGIL Surveillance Study GroupArticle first published

online: 25 JUL 2011

DOI: 10.1002/hep.24406

Copyright © 2011 American Association for the Study of Liver Diseases

Issue

Hepatology

Volume 54, Issue 2, pages 443–451, August 2011

Abstract

Entecavir (ETV) is a potent inhibitor of viral replication in nucleos(t)ide

analogue (NA)-naïve chronic hepatitis B (CHB) patients. The aim of this study

was to investigate the long term efficacy and safety of ETV in NA-naïve CHB

patients, particularly in those with detectable hepatitis B virus (HBV) DNA

after 48 weeks, in whom treatment adaptation is suggested by current guidelines.

In a multicenter cohort study, we investigated 333 CHB patients treated with

entecavir monotherapy. The NA-naïve population consisted of 243 patients,

whereas 90 were NA-experienced. Virological response (VR) (HBV DNA <80 IU/mL)

was achieved in 48%, 76%, and 90% of hepatitis B e antigen (HBeAg)-positive and

in 89%, 98%, and 99% of HBeAg-negative NA-naïve patients at weeks 48, 96, and

144, respectively. Thirty-six of 175 (21%) NA-naïve patients with at least 48

weeks of follow-up had a detectable load at week 48 (partial virological

response [PVR]). Twenty-nine (81%) patients with PVR reached VR during prolonged

ETV monotherapy, and none of them developed ETV-resistance. Among 22 patients

with HBV DNA <1,000 IU/mL at week 48, VR was achieved in 21 (95%) patients,

compared with eight of 14 (57%) patients with HBV DNA ≥1,000 IU/mL. Continuous

HBV DNA decline was observed in most patients without VR during follow-up, and

in three patients adherence was suboptimal according to the treating physician.

ETV was safe and did not affect renal function or cause lactic acidosis.

Conclusion: ETV monotherapy can be continued in NA-naïve patients with

detectable HBV DNA at week 48, particularly in those with a low viral load

because long-term ETV leads to a virological response in the vast majority of

patients. (HEPATOLOGY 2011;)

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1002/hep.24406/abstract

Entecavir treatment for chronic hepatitis B: Adaptation is not needed for the

majority of naïve patients with a partial virological response†‡

Roeland Zoutendijk1, Jurriën G. P. Reijnders1, Brown2, Fabien Zoulim3,

Mutimer4, Katja Deterding5, Jörg sen6, Wolf Hofmann7,

Buti8, Santantonio9, Florian van Bömmel10, Pierre Pradat3, Ye Oo4, Marc

Luetgehetmann11, Berg10, Bettina E. Hansen1, Heiner Wedemeyer5, Harry L.

A. Janssen1,*,§, for the VIRGIL Surveillance Study GroupArticle first published

online: 25 JUL 2011

DOI: 10.1002/hep.24406

Copyright © 2011 American Association for the Study of Liver Diseases

Issue

Hepatology

Volume 54, Issue 2, pages 443–451, August 2011

Abstract

Entecavir (ETV) is a potent inhibitor of viral replication in nucleos(t)ide

analogue (NA)-naïve chronic hepatitis B (CHB) patients. The aim of this study

was to investigate the long term efficacy and safety of ETV in NA-naïve CHB

patients, particularly in those with detectable hepatitis B virus (HBV) DNA

after 48 weeks, in whom treatment adaptation is suggested by current guidelines.

In a multicenter cohort study, we investigated 333 CHB patients treated with

entecavir monotherapy. The NA-naïve population consisted of 243 patients,

whereas 90 were NA-experienced. Virological response (VR) (HBV DNA <80 IU/mL)

was achieved in 48%, 76%, and 90% of hepatitis B e antigen (HBeAg)-positive and

in 89%, 98%, and 99% of HBeAg-negative NA-naïve patients at weeks 48, 96, and

144, respectively. Thirty-six of 175 (21%) NA-naïve patients with at least 48

weeks of follow-up had a detectable load at week 48 (partial virological

response [PVR]). Twenty-nine (81%) patients with PVR reached VR during prolonged

ETV monotherapy, and none of them developed ETV-resistance. Among 22 patients

with HBV DNA <1,000 IU/mL at week 48, VR was achieved in 21 (95%) patients,

compared with eight of 14 (57%) patients with HBV DNA ≥1,000 IU/mL. Continuous

HBV DNA decline was observed in most patients without VR during follow-up, and

in three patients adherence was suboptimal according to the treating physician.

ETV was safe and did not affect renal function or cause lactic acidosis.

Conclusion: ETV monotherapy can be continued in NA-naïve patients with

detectable HBV DNA at week 48, particularly in those with a low viral load

because long-term ETV leads to a virological response in the vast majority of

patients. (HEPATOLOGY 2011;)

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1002/hep.24406/abstract

Entecavir treatment for chronic hepatitis B: Adaptation is not needed for the

majority of naïve patients with a partial virological response†‡

Roeland Zoutendijk1, Jurriën G. P. Reijnders1, Brown2, Fabien Zoulim3,

Mutimer4, Katja Deterding5, Jörg sen6, Wolf Hofmann7,

Buti8, Santantonio9, Florian van Bömmel10, Pierre Pradat3, Ye Oo4, Marc

Luetgehetmann11, Berg10, Bettina E. Hansen1, Heiner Wedemeyer5, Harry L.

A. Janssen1,*,§, for the VIRGIL Surveillance Study GroupArticle first published

online: 25 JUL 2011

DOI: 10.1002/hep.24406

Copyright © 2011 American Association for the Study of Liver Diseases

Issue

Hepatology

Volume 54, Issue 2, pages 443–451, August 2011

Abstract

Entecavir (ETV) is a potent inhibitor of viral replication in nucleos(t)ide

analogue (NA)-naïve chronic hepatitis B (CHB) patients. The aim of this study

was to investigate the long term efficacy and safety of ETV in NA-naïve CHB

patients, particularly in those with detectable hepatitis B virus (HBV) DNA

after 48 weeks, in whom treatment adaptation is suggested by current guidelines.

In a multicenter cohort study, we investigated 333 CHB patients treated with

entecavir monotherapy. The NA-naïve population consisted of 243 patients,

whereas 90 were NA-experienced. Virological response (VR) (HBV DNA <80 IU/mL)

was achieved in 48%, 76%, and 90% of hepatitis B e antigen (HBeAg)-positive and

in 89%, 98%, and 99% of HBeAg-negative NA-naïve patients at weeks 48, 96, and

144, respectively. Thirty-six of 175 (21%) NA-naïve patients with at least 48

weeks of follow-up had a detectable load at week 48 (partial virological

response [PVR]). Twenty-nine (81%) patients with PVR reached VR during prolonged

ETV monotherapy, and none of them developed ETV-resistance. Among 22 patients

with HBV DNA <1,000 IU/mL at week 48, VR was achieved in 21 (95%) patients,

compared with eight of 14 (57%) patients with HBV DNA ≥1,000 IU/mL. Continuous

HBV DNA decline was observed in most patients without VR during follow-up, and

in three patients adherence was suboptimal according to the treating physician.

ETV was safe and did not affect renal function or cause lactic acidosis.

Conclusion: ETV monotherapy can be continued in NA-naïve patients with

detectable HBV DNA at week 48, particularly in those with a low viral load

because long-term ETV leads to a virological response in the vast majority of

patients. (HEPATOLOGY 2011;)

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1002/hep.24406/abstract

Entecavir treatment for chronic hepatitis B: Adaptation is not needed for the

majority of naïve patients with a partial virological response†‡

Roeland Zoutendijk1, Jurriën G. P. Reijnders1, Brown2, Fabien Zoulim3,

Mutimer4, Katja Deterding5, Jörg sen6, Wolf Hofmann7,

Buti8, Santantonio9, Florian van Bömmel10, Pierre Pradat3, Ye Oo4, Marc

Luetgehetmann11, Berg10, Bettina E. Hansen1, Heiner Wedemeyer5, Harry L.

A. Janssen1,*,§, for the VIRGIL Surveillance Study GroupArticle first published

online: 25 JUL 2011

DOI: 10.1002/hep.24406

Copyright © 2011 American Association for the Study of Liver Diseases

Issue

Hepatology

Volume 54, Issue 2, pages 443–451, August 2011

Abstract

Entecavir (ETV) is a potent inhibitor of viral replication in nucleos(t)ide

analogue (NA)-naïve chronic hepatitis B (CHB) patients. The aim of this study

was to investigate the long term efficacy and safety of ETV in NA-naïve CHB

patients, particularly in those with detectable hepatitis B virus (HBV) DNA

after 48 weeks, in whom treatment adaptation is suggested by current guidelines.

In a multicenter cohort study, we investigated 333 CHB patients treated with

entecavir monotherapy. The NA-naïve population consisted of 243 patients,

whereas 90 were NA-experienced. Virological response (VR) (HBV DNA <80 IU/mL)

was achieved in 48%, 76%, and 90% of hepatitis B e antigen (HBeAg)-positive and

in 89%, 98%, and 99% of HBeAg-negative NA-naïve patients at weeks 48, 96, and

144, respectively. Thirty-six of 175 (21%) NA-naïve patients with at least 48

weeks of follow-up had a detectable load at week 48 (partial virological

response [PVR]). Twenty-nine (81%) patients with PVR reached VR during prolonged

ETV monotherapy, and none of them developed ETV-resistance. Among 22 patients

with HBV DNA <1,000 IU/mL at week 48, VR was achieved in 21 (95%) patients,

compared with eight of 14 (57%) patients with HBV DNA ≥1,000 IU/mL. Continuous

HBV DNA decline was observed in most patients without VR during follow-up, and

in three patients adherence was suboptimal according to the treating physician.

ETV was safe and did not affect renal function or cause lactic acidosis.

Conclusion: ETV monotherapy can be continued in NA-naïve patients with

detectable HBV DNA at week 48, particularly in those with a low viral load

because long-term ETV leads to a virological response in the vast majority of

patients. (HEPATOLOGY 2011;)